Transcription of QSIT Points to Consider-Design ControlFINAL
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QSIT Points to Consider-Design ControlFINAL
Points TO consider WHEN PREPARING FOR AN FDA. INSPECTION UNDER THE QSIT design CONTROLS. SUBSYSTEM. MAY 15, 2003. Bringing innovation to patient care worldwide 1200 G Street NW, Suite 400. Washington, DC 20005 3814. Tel: 202 783 8700. Fax: 202 783 8750. ACKNOWLEDGEMENT. This document was authored by Frederick F. Schweitzer, Welch Allyn, Inc. Assistance was provided by: Annette Hillring Frances Akelewicz Nancy Singer Pamela J. Weagraff Hillring & Associates, Inc. Practical Solutions, LLC AdvaMed MediSpectra, Inc Many other people also contributed to the ideas contained in the document.
3 of 21 Introduction Background Effective June 1, 1997, the Food and Drug Administration (FDA) revised the Current Good Manufacturing Practice (CGMP) requirements for medical devices and incorporated them into the
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